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University of Texas H.S.C. San Antonio Pioglitazone in Non-Alcoholic Steatohepatitis Trial (UTHSCSA NASH Trial)

NCT00994682 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2017-04-05

Study results available
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Summary

Obesity and Type 2 diabetes are creating a silent epidemic, Non-alcoholic fatty liver disease, which is a chronic liver disease associated with insulin resistance, impaired glucose intolerance, and hepatic fat accumulation. The thiazolidinedione pioglitazone improves glucose/lipid metabolism and histology in NASH by improving insulin resistance in the liver/peripheral/adipose tissues and reducing subclinical inflammation. The aim of this study is to assess the underlying mechanisms at the clinical and molecular level and the long-term efficacy and safety of pioglitazone in NASH in a multiethnic cohort of subjects (predominantly Hispanics, Caucasians and African-Americans - the most common ethnic groups locally) and examine the response including patients with normal glucose tolerance, impaired glucose tolerance or established type 2 diabetes mellitus (T2DM).

Conditions

Interventions

DRUG

Pioglitazone study drug

30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months

DRUG

Placebo

An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.

DRUG

Pioglitazone Open Label

Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design.

Sponsors & Collaborators

  • The University of Texas at San Antonio

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Kenneth Cusi, M.D. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00994682 on ClinicalTrials.gov